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FDA accepts Allergan's NDA for oxymetazoline HCl cream; action date H1 2017

May 24, 2016 7:52 AM ETAllergan plc (AGN) StockAGNBy: Douglas W. House, SA News Editor6 Comments
  • The FDA accepts for review the New Drug Application (NDA) from Allergan (NYSE:AGN) seeking approval of oxymetazoline HCl cream 1.0% for the treatment of persistent facial erythema (redness) associated with rosacea in adults. The FDA's action date (PDUFA) should be in H1 2017.
  • Rosacea is a chronic skin condition affecting more than 16M Americans. It generally affects adults between the ages of 30 and 60 years of age.

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